FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06959664911228
·
Model: AG-55344-2300-090-16S
·
Hangzhou AGS MedTech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06959664911228
- Version / Model
- AG-55344-2300-090-16S
- Company Name
- Hangzhou AGS MedTech Co., Ltd.
- Labeler DUNS
- 542984702
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-05
- Public Version
- 1
- Public Version Date
- 2018-08-06
- Public Version Status
- New
- Public Device Record Key
- d775488e-a83b-485f-818a-cdb4a58ce97f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61207 | Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 66959664911220 | GS1 | 10 | In Commercial Distribution | ||
| Package | 56959664911223 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 06959664911228 | GS1 | ||||
| Package | 26959664911222 | GS1 | 5 | In Commercial Distribution | ||
| Package | 16959664911225 | GS1 | 10 | In Commercial Distribution | ||
| Package | 46959664911226 | GS1 | 25 | In Commercial Distribution | ||
| Package | 36959664911229 | GS1 | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172727 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity